Evaluate Tolerability of Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations
This study is designed to evaluate the tolerability of Myfortic®/Simulect® combination in diabetic patients in a steroid free regimen. Due to the diverse ethnicity of our transplant recipient population, our study will determine any different responses, including autoimmunity, between Hispanic, and Caucasian, patients.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study to Evaluate Tolerability of Myfortic With Simulect Induction and Tacrolimus Without Steroids in Three Patient Populations; 1: Kidney/Pancreas Transplants,2: Diabetic Kidney Transplants, and 3: Non-diabetic Kidney Transplants|
- Tolerability of Myfortic in combination with Simulect and Tacrolimus without steroids [ Time Frame: 24 months ] [ Designated as safety issue: No ]Assure that immunosuppression protects graft function by decreased incidence of rejection and side effects
- GI complications [ Time Frame: 24 months ] [ Designated as safety issue: No ]Gastric emptying test
- Graft function [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Renal function assessed by serum creatinine and calculating creatinine clearance.
Pancreas function assessed by glucose control, exogenous insulin requirement, HgbA1C
- Biopsy proven rejection [ Time Frame: 24 months ] [ Designated as safety issue: No ]Renal graft core biopsy will be performed on all suspected rejection.
|Study Start Date:||March 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Transplant recipients
All subjects receive identical drug treatment
Procedure: Gastric emptying test
Gastric emptying tests will be performed at baseline, 6 months and 12 months
Myfortic® is an enteric-coated formulation of the sodium salt derivative of mycophenolic acid (MPA) that is administered to control kidney graft rejection. Myfortic® was developed to improve MPA-related upper gastrointestinal (GI) side effects by delaying the release of MPA until it reaches the large surface of the small bowel. Approximately half of all the kidney transplant recipients in the United States have diabetes mellitus. A recent analysis of approximately 30,000 kidney transplant recipients included in the U.S. Renal Data System showed that 42% of patients had pre-transplant diabetes (1). Moreover, 15% to 20% of patients develop diabetes after transplantation, a condition that is commonly known as post-diabetes mellitus (1-3). It was previously shown that the rate and extent of MPA absorption is minimally affected by diabetes (4). Limited data is available in the current literature on Myfortic® and Simulect® based therapy in diabetic patients.
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555|
|Principal Investigator:||Luca Cicalese, MD||University of Texas|